Cybersecurity, Supply Chain Security, Good Distribution Practices and FDA’s Drug Registration Process

• cybersecurity regulations
• the benefits of serialization software
• EU GDP guideline five years later
• an overview of the current Israeli regulatory system
• conflicts with separate drug approval in adults and children
• components of FDA’s drug registration process
• how to perform a GMP audit
• the benefits of visual data

Securing the Supply Chain

Over the past decade, there has been an enormous explosion of minute networked medical gadgets supporting an assortment of health maladies, right from the beating of the human heart to controlling severe diabetic conditions. Remote access to such devices and their association with PCs or other networked gadgets spares time, cash and resources. However, this leaves them exposed to theft, scams and exploitation. “Cybersecurity Susceptibilities in Networked Medical Devices” discusses how the US medical device industry is facing cybersecurity risks due to their wireless connectivity over the internet. Two research experts, Kalpit Patel and Stephen Amato, provide a brief overview of the common types of cyberthreats and the medical devices affected and describes the regulations in place to oversee this issue.

The European Union’s Falsified Medicines Directive (FMD) is a regulation designed to protect public health by securing the European Union’s pharmaceutical supply chain against counterfeit medicines.

Similarly, the United States’ Drug Supply Chain Security Act (DSCSA), outlines steps for building an electronic, interoperable system to track and trace prescription drugs as they are distributed in the US in an attempt to protect consumers from exposure to prescription medicines that may be counterfeit, stolen, contaminated or otherwise harmful. Entrepreneur, Glenn Abood, outlines how serialization software can unlock additional value beyond regulatory compliance for both patients and those in the pharmaceutical industry and discusses how using track and trace functions also provide protection against counterfeit, stolen or contaminated drugs. “Vision and Visibility: Converting Compliance into Competitive Advantage” explains how forward-thinking organizations are using serialization software to enhance operational efficiency, partner engagement and stronger patient-centered care.

Why are governments mandating the pharmaceutical products be serialized? Regulatory expert, Tom Mercolino, answers this questions in addition to describing the complementary role of authentication in serialization programs. “Integrated Pharmaceutical Supply Chain Security Through Serialization and Authentication” is the first article in a series designed to give regulatory professionals and other managers in the pharmaceutical industry an understanding of government mandates for product serialization and to highlight certain key related issues.

On 5 November 2018, the current EU GDP Guideline turned five years old, but what have regulatory professionals learned in those five years? Have we succeeded in achieving a better protection of the integrity of pharmaceutical products and fortified patient safety? What did it mean for the R&D industry, the drug manufacturers and their service partners in the supply chain? In the article, “Safety First,” Michael Fleischer and Jens Mattuschka, review the development of global Good Distribution Practices (GDPs) against the background of an increasingly complex pharmaceutical supply chain, five years after the initial implementation of the extended EU GDP Guideline.

Quality and Compliance

All domestic and foreign firms manufacturing, preparing, propagating, compounding or processing drugs in the US or importing drugs into the US must register with the US FDA. Olivia Lu describes these detailed processes in “FDA’s Drug Establishment Registration Process.” Lu covers vital components of the registration process, including information on a firm’s DUNS Number, the Establishment Registration Structured Process Labeling (SPL) document, submitting the SPL and updating or changing an FDA registration.

Hear from regulatory professional Rehan Shah as he describes the first-time experience of performing an audit. In “Performing a GMP Audit,” Shah explains why audits should be conducted, summarizes key aspects of performing an audit and explains how findings might provide insight into the “bigger picture” of how hands-on manufacturing and good manufacturing practices are conducted in addition to being incorporated into daily role of a regulatory professional.

Milena Samban discusses product quality, importation, manufacturing, storage and distribution of pharmaceuticals in Israel and the regulatory context for these topics. “Integrated Quality Systems: An Overview of the Current Israeli Regulatory System,” explains that while many international pharmaceutical companies operate in Israel and the regulation of pharmaceuticals in Israel is generally aligned with the European Union (EU) regulations, there are a number of differences between the two regulatory systems.

Science and Research

In “Separate Drug Approval in Children is not Based on Science,” Klaus Rose and Jane Grant-Kels discuss the flaws and historical roots of separate drug approval in adults and children, caused by exaggerated warnings of drug toxicities, which are appropriate for newborns, but not for all minors until they become adult. The authors reveal what they believe to be some hidden conflicts of interest between industry and regulatory authorities.  

As part of management review, teaching, panel meetings, budgets or during an inspection by notified bodies or regulatory agencies, regulatory personnel are frequently called upon to provide data to diverse individuals. Regulatory veteran, Max Sherman, discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. Sherman’s article, “Visualizing Data,” offers thoughts on software programs and books that may serve as good sources for learning more about visual data presentation.

What’s Ahead in 2019

RAPS Regulatory Focus will kick off 2019 with a spotlight on regulatory intelligence strategy and policy.

Articles will identify regulatory trends, analyze how ripples and shifts in the landscape will need to be addressed by companies, forecast the future of the regulatory landscape and determine the impact to internal and external regulatory policies. Q1 will also feature risk management and quality issues.

Ideas?

Send comments and recommend topics for feature article or series to ghall@raps.org. I welcome your feedback.